Moderna is seeking a Quality Control Specialist for a position based at their Norwood, MA site. The individual in this role will support external testing and program activities for outsourced late phase clinical manufacturing. He/she will support testing programs and will support investigations for out-of specification and other non-conforming results as well as troubleshooting of assays. The individual will act as interdepartmental liaison to various groups as well as Quality Control contact to the contract manufacturing organizations and testing labs.
Here's What You'll Do
Here's What You'll Need (Minimum Qualifications)
- Assist in testing program support at contract manufacturing organizations and contract laboratories for raw materials, drug substance and drug product
- Participate in cross-functional project team to lead Quality Control related activities
- Oversee method transfers and validations projects as required
- Troubleshoot and provide further technical support for method, material, and instrument related issues
- Review/approve procedures, protocols and reports
- Support technical assessments of deviations and investigations
- Additional duties as may be assigned from time to time
Here's What You'll Bring to the Table (Preferred Qualifications)
- Bachelor's degree in a relevant scientific discipline
- 3-5 years in a cGMP laboratory with focus in analytical chemistry or prior experience managing contract laboratories
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- At least 4 years in an analytical chemistry capacity in analytical testing, data review, data entry, and use of a LIMS system.
- Prior experience interfacing with contract testing labs or CMOs
- High attention to detail and ability to follow cGMP regulations
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.